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Recruiting NCT07008820

Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan

Trial Parameters

Condition Myelodysplastic Syndrome (MDS)
Sponsor Bristol-Myers Squibb
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-05-13
Completion 2026-02-28
Interventions
Health-related quality of life questionnairesQualitative interviews

Brief Summary

This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan

Eligibility Criteria

Inclusion Criteria: The inclusion criteria for the quantitative phase will include either 1 or 2 and all of 3-6: 1. Low Risk Myelodysplastic Syndromes (LR MDS) erythropoietin stimulating agent (ESA) naïve non-transfusion dependent (NTD) patrticipants: identified with confirmed via bone marrow aspirate and \< 5% blasts in bone marrow. Lower-risk is defined by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R), as follows: * Very low, low, or intermediate-risk (score ≤ 3.5) as assessed by IPSS-R * Low or intermediate-1 (score ≤ 1) as assessed by IPSS 2. Unexplained anemia with suspected MDS: identified anemia with general anemia (iron/vitamin deficiency, bleeding, renal, etc.) excluded 3. Participants with hemoglobin in the most recent blood test \< 10.0 g/dl, or the average of hemoglobin \< 10.0g/dl in the most recent 2 blood tests conducted within 30 days prior to enrollment in this study 4. Participants who are ≥ 18 years of age

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